None listed
Conditions
Brief summary
Randomized controlled trial study carried out at the Normal Birth Center of Amparo Maternal, a public maternity located in Sao Paulo, Brazil. The women were divided in three groups: Experimental Group – ice pack applied to the perineum; Placebo Group – environmental temperature water pack applied to the perineum and Control Group – did not receive pack. The pack was applied during twenty minutes, and in the three groups perineum temperature was controlled before (T0= first moment) and after (T20=after 20 minutes) this intervention. A digital Minipa (registered trade mark) model MT 405 thermometer was used to monitore the perineum temperature. The temperatures of maternity room, packs (ice and water) and women body were also controlled. Pain magnitude was evaluated by the numeric scale represented by a horizontal line with numerical marks from zero to ten; the zero value denoted no pain and the ten value denoted the worst imaginable pain. The women were allocated to the experimental, placebo or control groups according to a computer generated randomisation list. Prior to her inclusion in the study, each woman received a detailed explanation of the purpose and the methods of the study. A signed consent was obtained from all voluntary participants, who were assured the right to withdraw from the study at any time.
Interventions
There are 3 groups of subjects receiving the interventions; ice pack, water pack and no treatment given. The group receiving water pack be was called 'placebo' and the group receiving ice pack was called experimental group. We apply packs in perineum for twenty minutes in each one. The ice pack and placebo are given to the subjects between 2 until 48 hours after delivery.
Sponsors
Fundacao de Amparo a Pesquisa do Estado de Sao Paulo.
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
=18 years-old; full-term nulliparous women with a live, cephalic presenting singleton fetus, with normal deliveries women, with or without perineal trauma and pointed out pain in the perineum =3 in numerical scale, between 2 and 48 hours of post-partum, didn’t receive anesthesia or painkillers for the last 2 hours, absence of clinical or obstetrical complications, and had a child with no incidents
Exclusion criteria
Women with pain 2 or 1 in Number scale, with with 2 or more births, women with less than 17 years old.
Outcome results
None listed